Randomised, double-blind, multicentre, mixed-methods, dose-escalation feasibility trial of mirtazapine for better treatment of severe breathlessness in advanced lung disease (BETTER-B feasibility)

Irene J. Higginson, Andrew Wilcock, Miriam J. Johnson, Sabrina Bajwah, Natasha Lovell, Deokhee Yi, Simon P. Hart, Vincent Crosby, Heather Poad, David Currow, Emma Best, Sarah Brown, BETTER-B Feasibility Trial Group, I Higginson, Jackie Pullen, Katie Neville, Victoria Hiley, Vicky Liversedge, Sarah Brown, Avie-Lee TillotsonNatasha Lovell, Miriam J. Johnson, Andrew Wilcock, David Currow, Deokhee Yi, M Paine

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    Abstract

    New treatments are required for severe breathlessness in advanced disease. We conducted a randomised feasibility trial of mirtazapine over 28 days in adults with a modified medical research council breathlessness scale score ≥3. Sixty-four patients were randomised (409 screened), achieving our primary feasibility endpoint of recruitment. Most patients had COPD or interstitial lung disease; 52 (81%) completed the trial. There were no differences between placebo and mirtazapine in tolerability or safety, and blinding was maintained. Worst breathlessness ratings at day 28 (primary clinical activity endpoint) were, 7.1 (SD 2.3, placebo) and 6.3 (SD 1.8, mirtazapine). A phase III trial of mirtazapine is indicated. Trial registration: ISRCTN 32236160; European Clinical Trials Database (EudraCT no: 2015-004064-11).

    Original languageEnglish
    Pages (from-to)176-179
    Number of pages4
    JournalThorax
    Volume75
    Issue number2
    DOIs
    Publication statusPublished - Feb 2020

    Bibliographical note

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

    Keywords

    • COPD exacerbations
    • COPD pharmacology
    • drug reactions
    • emphysema
    • idiopathic pulmonary fibrosis
    • lung cancer
    • palliative care
    • psychology

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